National Drug Code (NDC) Assignment Guide

Drug Establishment Registration Reporting Requirements

Reed Tech SPL Solutions

The FDA recently introduced two significant changes to its process for drug listing products manufactured by contract manufacturing organizations (CMOs). It is important for CMOs and Private Label Distributors (PLDs) to understand these changes and make sure they...

You may have seen one of our recent posts about the FDA’s new Blanket No Change Certification submission requirement for drug products. If not, you can get a quick rundown of the requirements here. To help track compliance with the new requirements, FDA has added a...

In this webinar, you’ll get an overview of the requirements for FDA’s new Blanket No Change Certification submission type for drug product listings. Presenter Jon Nolan will address the following: What’s Changing Requirements and Timelines Questions...

As part of the 2016 Final Rule on Electronic Drug Listing, FDA introduced important new changes that affect all human drug product labelers and manufacturers. Beginning in 2017, every existing human drug product listing must be either 1) updated during the course of...

In this webinar, you’ll get an overview of the FDA’s requirements for submissions during the annual reporting period to the electronic Drug Registration and Listing (eDRL) system. That includes drug product site Establishment Registrations and a brand new...

Yes, you read that correctly. There are significant changes coming to the FDA’s electronic Drug Registration and Listing System (eDRLS) that require action from most drug labelers before the end of the year. You may have heard that, as part of the eDRL Final Rule...

Did you know that Health Canada, the department of the Canadian government that regulates drug products, is engaged in a pilot program to introduce electronic submissions of drug product information in Structured Product Labeling (SPL) format? Officially named the...

Every product on the market in the U.S. containing an active drug ingredient is required to be electronically drug listed with the FDA and assigned a National Drug Code (NDC). During this process, drug labelers submit complete electronic copies of the Content of...

Each company responsible for submitting drug product listings will have its own unique schedule for submission to FDA based on application approval dates and updates to labeling and listing information. However, FDA has established several specific reporting periods...

GDUFA, or the Generic Drug User Fee Amendments, were passed by Congress in 2012, with the purpose of “speed[ing] access to safe and effective generic drugs to the public and reduc[ing] costs to industry.” Among other things, the initiative authorized FDA to collect...

If your company manufactures drug products for distribution in the United States, you probably know that you are required to register your establishment site(s) annually with FDA in Structured Product Labeling (SPL) format. Many manufacturers are unaware, however,...

One of the topics our team receives frequent questions about is National Drug Codes (NDCs). How are they structured? Where do they come from? What’s the difference between an NDC labeler code, product code and package code? To help industry members understand...

As you may know, FDA recently began accepting Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling (SPL) format. Although the FDA’s targeted date for acceptance was delayed slightly from September 2, the agency told us that it is...

Part of the FDA’s requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). An NDC is a 10 digit number that uniquely identifies a drug product by stringing together three separate code segments. A complete...

Drug establishment sites are any facilities which “manufacture, prepare, propagate, compound or process” drug products for commercial distribution or import into the United States. These include sites engaging in the manufacture of human health prescription drug...